Clinical Trial Project Leader - Pharma

Skills :

- Education - M.Pharm or equivalent with solid clinical trial monitoring experience (6-8 years) for dermal formulations, demonstrating successful performance of Clinical Research Associate position

- At least 6 full years experience as a CRA including all steps of the clinical study; i.e. site initiation, site monitoring and site closure

- Exposure to US market filings for ANDA/NDA of Dermatology products is preferred

- Should have previously worked with multiple CROs, both in India and USA

- Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines

- Good command of written and spoken English language

- Good organizational skills, analytical and social skills

- Ability to maintain effective, professional communication

- Ability to prioritize and manage multiple tasks

- Ability to manage and supervise study team members

- Ability to handle multiple tasks with conflicting deadlines and be able to prioritize

Responsibilities :

- Inviting proposal for clinical trials

- Selection of CROs for clinical trials

- Review of Clinical trial protocols

- Preparing and conducting pre-study activities, site selection, initiation visits, routine monitoring and close-out visits

- Performing feasibility

- Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities

- Planning and participating at Investigator's meeting(s)

- Responsible for the site(s) and on-site management during the study process

- Ordering and coordinating study supplies

- Preparing study documentation and assisting the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site

- Negotiating contracts with the clinics, local/central laboratory(ies)/pharmacy etc.

- Responsibility for the final archiving of all study documentation in-house

- Monitoring and Oversight - communicating with study teams and sponsors

- Regulatory Documentation Management

- Administration - Providing status Reports to line manager

- Planning budget activities for the trials

- Managing timelines and deliverables for the trials

- Bridget between trial site and CMC team for the supply of trial medications

CTC : Up to 15 lacs ( can be extended for good candidates )

Please mention number of topical/derma products handled for Indian, European and US market (ANDAs) in the CV.